FDA unveils 10-year FSMA implementation plan

By Hank Schultz

- Last updated on GMT

©Getty Images - Alex Raths
©Getty Images - Alex Raths

Related tags Food safety Traceability FSMA Food safety modernization

The US Food and Drug Administration yesterday launched a website portal it calls a ‘blueprint’ for the full implementation of the Food Safety Modernization Act. The document lays out a plan for actions over the next decade.

Titled A New Era in Food Safety,​ the stated goal of the initiative is to bring the revamping of the food system up to speed with changes in the marketplace and in the technology of the production of food, food ingredients and dietary ingredients for supplements.  The planned launch of the initiative was delayed by the pandemic, the Agency said.

“Many believe we will see more changes in the food system over the next 10 years than we have in decades. Foods are being reformulated; there are new foods, new production methods, and new delivery methods; and the system is becoming increasingly digitized,” ​said FDA Commissioner Dr Stephen MD, a statement.

“To keep pace with this evolution, FDA is taking a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system,”​ he added.

"At UNPA, we were excited to read the announcement. I follow Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, and his previous work in the food industry. He has held positions in the food industry focusing on food safety and traceability for Walmart and Disney. This announcement, while a team effort at the FDA, looks very similar to Frank Yannas's previous focus and efforts while he worked in the industry.  I was happy to see him join the FDA. Historically, I have seen some "FDA lifers" who have not had the necessary industry experience or expertise to incorporate standard business practices for the industry into policy and to make realistic suggestions for improvements,"​ said Larisa Pavlick, vice president of global regulatory and compliance for the United Natural Products Alliance.

Four basic tenets

FDA said its so-called “New Era Blueprint” ​is organized around four basic principles:

  • Tech-enabled Traceability
  • Smarter Tools and Approaches for Prevention and Outbreak Response
  • New Business Models and Retail Modernization
  • Food Safety Culture.

FDA said this approach was informed with the input of “FDA food safety experts, consumers, the food industry, technology firms, federal and state regulatory partners, our regulatory counterparts in other nations, and academia.”

When FSMA was first enacted it appeared that the dietary supplement industry would be only tangentially affected.  But observers came to understand that many ingredient producers, who had been specifically exempted from the GMP provisions under DSHEA, would fall under its provisions.  And the Foreign Supplier Verification Program (FSVP) is now high on the radar of many dietary supplement suppliers.

 Better record keeping for more transparency

FDA said it intends to push for a transformation of food and dietary ingredient record keeping.  Much of this is still done on paper, which hinders the Agency’s timely response to outbreaks of food borne illnesses.   The Agency said it also intends to push for greater transparency in the supply chain, while still being mindful of confidentiality and proprietary interests.

"This is a welcome and overdue update for the agency. Having worked inside the agency as an investigator as well as on the industry side, I was surprised by the technology and systems within the agency. The industry perception is big brother is watching but the reality is, we had carbon forms.  Enhanced technology along with FDA officials with industry expertise is a welcome change for the agency,"​ Pavlick added.

Industry observers often start running the cost calculators in their heads when such new regulatory goals are announced.  FDA seemed to be trying to head those concerns off at the pass when it added that it would “Encourage food traceabilitytechnology providers to develop creative financial models that are low- to no-cost solutions, proportional to benefits derived from participating, and enabling food producers of all sizes to participate in a scalable, cost-effective way.”

Summit on new food business model

The Agency also said it intends to convene a summit to come up with a new food business model.  And it has a goal to foster new food ingredients and production technologies.

“We know from our experience during the pandemic that the blueprint involves ideas whose time has come. Implementing them will strengthen our ability to protect the food supply in good times and bad. And it will allow us to change as our world changes and the challenges and opportunities of food technology evolve,”​ Hahn said.

For more on the blueprint, visit FDA’s web portal​.

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